{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T09:18:55Z","timestamp":1768036735003,"version":"3.49.0"},"reference-count":27,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,2,26]],"date-time":"2020-02-26T00:00:00Z","timestamp":1582675200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,2,26]],"date-time":"2020-02-26T00:00:00Z","timestamp":1582675200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004326","name":"Bayer AG","doi-asserted-by":"crossref","award":["n\/a"],"award-info":[{"award-number":["n\/a"]}],"id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Nephrol"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n<jats:title>Background<\/jats:title>\n<jats:p>Limited evidence has indicated that addition of a steroidal mineralocorticoid receptor antagonist (MRA) to the standard of care reduces proteinuria in patients with diabetic kidney disease (DKD); however, there are limited data regarding real-world MRA use in these patients. This study aimed to describe the characteristics of spironolactone users and non-users with DKD, and to explore their clinical outcomes.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>This was a non-interventional, retrospective cohort study using demographic and clinical data from a US claims database (PharMetrics Plus) and the Experian consumer data asset during 2006\u20132015. Baseline characteristics (e.g. comorbidities) and post-inclusion clinical outcomes were described in matched cohorts of spironolactone users and non-users (<jats:italic>n<\/jats:italic>\u00a0=\u20095465 per group).<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>Although matching aligned key demographic and clinical characteristics of the cohorts, a significantly greater proportion of spironolactone users than non-users had oedema, proteinuria, and cardiovascular disease at baseline (<jats:italic>P<\/jats:italic>\u00a0&lt;\u20090.0001). During the post-inclusion period, disease progression and clinical events of interest such as acute kidney injury were more commonly observed in spironolactone users than non-users. Users also had higher healthcare resource utilization and costs than non-users; however, these differences diminished at later stages of disease.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusions<\/jats:title>\n<jats:p>In this study, spironolactone users had a greater comorbidity burden at baseline than matched non-users, suggesting that the presence of certain comorbidities may be contributing factors in the decision to prescribe spironolactone. High healthcare resource utilization and costs for patients at later stages of disease, irrespective of spironolactone use, highlight the need for new therapies for DKD.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s12882-020-01719-7","type":"journal-article","created":{"date-parts":[[2020,2,26]],"date-time":"2020-02-26T13:02:48Z","timestamp":1582722168000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Disease characteristics and outcomes in patients with chronic kidney disease and type 2 diabetes: a matched cohort study of spironolactone users and non-users"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3886-1052","authenticated-orcid":false,"given":"Michael","family":"Blankenburg","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Csaba P.","family":"Kovesdy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne-Kathrin","family":"Fett","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raymond G.","family":"Griner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alain","family":"Gay","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,2,26]]},"reference":[{"key":"1719_CR1","unstructured":"Kidney Disease: Improving Global Outcomes (KDIGO) CKD work group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl. 2013;3:1\u2013150."},{"key":"1719_CR2","doi-asserted-by":"publisher","first-page":"S105","DOI":"10.2337\/dc18-S010","volume":"41","author":"American Diabetes Association","year":"2018","unstructured":"American Diabetes Association. 10. Microvascular complications and foot care: standards of medical care in diabetes \u2013 2018. Diabetes Care. 2018;41:S105\u201318.","journal-title":"Diabetes Care"},{"key":"1719_CR3","doi-asserted-by":"publisher","first-page":"e000154","DOI":"10.1136\/bmjdrc-2015-000154","volume":"4","author":"B Wu","year":"2016","unstructured":"Wu B, Bell K, Stanford A, Kern DM, Tunceli O, Vupputuri S, et al. Understanding CKD among patients with T2DM: prevalence, temporal trends, and treatment patterns\u2014NHANES 2007\u20132012. BMJ Open Diabetes Res Care. 2016;4:e000154.","journal-title":"BMJ Open Diabetes Res Care"},{"key":"1719_CR4","doi-asserted-by":"publisher","first-page":"e0192712","DOI":"10.1371\/journal.pone.0192712","volume":"13","author":"J Gatwood","year":"2018","unstructured":"Gatwood J, Chisholm-Burns M, Davis R, Thomas F, Potukuchi P, Hung A, et al. Evidence of chronic kidney disease in veterans with incident diabetes mellitus. PLoS One. 2018;13:e0192712.","journal-title":"PLoS One"},{"key":"1719_CR5","doi-asserted-by":"publisher","first-page":"2532","DOI":"10.1001\/jama.2011.861","volume":"305","author":"IH de Boer","year":"2011","unstructured":"de Boer IH, Rue TC, Hall YN, Heagerty PJ, Weiss NS, Himmelfarb J. Temporal trends in the prevalence of diabetic kidney disease in the United States. JAMA. 2011;305:2532\u20139.","journal-title":"JAMA"},{"key":"1719_CR6","doi-asserted-by":"publisher","first-page":"1813","DOI":"10.1681\/ASN.2008121270","volume":"20","author":"T Ninomiya","year":"2009","unstructured":"Ninomiya T, Perkovic V, de Galan BE, Zoungas S, Pillai A, Jardine M, et al. Albuminuria and kidney function independently predict cardiovascular and renal outcomes in diabetes. J Am Soc Nephrol. 2009;20:1813\u201321.","journal-title":"J Am Soc Nephrol"},{"key":"1719_CR7","doi-asserted-by":"publisher","first-page":"1833","DOI":"10.2337\/dc09-0191","volume":"32","author":"IH de Boer","year":"2009","unstructured":"de Boer IH, Katz R, Cao JJ, Fried LF, Kestenbaum B, Mukamal K, et al. Cystatin C, albuminuria, and mortality among older adults with diabetes. Diabetes Care. 2009;32:1833\u20138.","journal-title":"Diabetes Care"},{"key":"1719_CR8","doi-asserted-by":"publisher","first-page":"291","DOI":"10.1016\/j.jdiacomp.2017.12.003","volume":"32","author":"GA Nichols","year":"2018","unstructured":"Nichols GA, Deruaz-Luyet A, Hauske SJ, Brodovicz KG. The association between estimated glomerular filtration rate, albuminuria, and risk of cardiovascular hospitalizations and all-cause mortality among patients with type 2 diabetes. J Diabetes Complicat. 2018;32:291\u20137.","journal-title":"J Diabetes Complicat"},{"key":"1719_CR9","doi-asserted-by":"publisher","first-page":"155","DOI":"10.1001\/jamacardio.2017.4228","volume":"3","author":"B Scirica","year":"2018","unstructured":"Scirica B, Mosenzon O, Bhatt D, Udell J, Steg P, McGuire D, et al. Cardiovascular outcomes according to urinary albumin and kidney disease in patients with type 2 diabetes at high cardiovascular risk: observations from the SAVOR-TIMI 53 trial. JAMA Cardiol. 2018;3:155\u201363.","journal-title":"JAMA Cardiol"},{"key":"1719_CR10","doi-asserted-by":"publisher","first-page":"302","DOI":"10.1681\/ASN.2012070718","volume":"24","author":"M Afkarian","year":"2013","unstructured":"Afkarian M, Sachs MC, Kestenbaum B, Hirsch IB, Tuttle KR, Himmelfarb J, et al. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephol. 2013;24:302\u20138.","journal-title":"J Am Soc Nephol"},{"key":"1719_CR11","doi-asserted-by":"publisher","first-page":"2864","DOI":"10.2337\/dc14-1296","volume":"37","author":"KR Tuttle","year":"2014","unstructured":"Tuttle KR, Bakris GL, Bilous RW, Chiang JL, de Boer IH, Goldstein-Fuchs J, et al. Diabetic kidney disease: a report from an ADA consensus conference. Diabetes Care. 2014;37:2864\u201383.","journal-title":"Diabetes Care"},{"key":"1719_CR12","doi-asserted-by":"publisher","first-page":"861","DOI":"10.1056\/NEJMoa011161","volume":"345","author":"B Brenner","year":"2001","unstructured":"Brenner B, Cooper M, de Zeeuw D, Keane W, Mitch W, Parving H-H, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. New Engl J Med. 2001;345:861\u20139.","journal-title":"New Engl J Med"},{"key":"1719_CR13","doi-asserted-by":"publisher","first-page":"851","DOI":"10.1056\/NEJMoa011303","volume":"345","author":"EJ Lewis","year":"2001","unstructured":"Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001;345:851\u201360.","journal-title":"N Engl J Med"},{"key":"1719_CR14","doi-asserted-by":"publisher","first-page":"542","DOI":"10.7326\/0003-4819-138-7-200304010-00010","volume":"138","author":"T Berl","year":"2003","unstructured":"Berl T, Hunsicker LG, Lewis JB, et al. Cardiovascular outcomes in the irbesartan diabetic nephropathy trial of patients with type 2 diabetes and overt nephropathy. Ann Intern Med. 2003;138:542\u20139.","journal-title":"Ann Intern Med"},{"key":"1719_CR15","doi-asserted-by":"publisher","first-page":"913","DOI":"10.1038\/sj.ki.5000159","volume":"69","author":"S Suissa","year":"2006","unstructured":"Suissa S, Hutchinson T, Brophy JM, Kezouh A. ACE-inhibitor use and the long-term risk of renal failure in diabetes. Kidney Int. 2006;69:913\u20139.","journal-title":"Kidney Int"},{"key":"1719_CR16","first-page":"271","volume-title":"Heart failure","author":"P Kolkhof","year":"2017","unstructured":"Kolkhof P, Jaisser F, Kim S, Filippatos G, Nowack C, Pitt B. Steroidal and novel non-steroidal mineralocorticoid receptor antagonists in heart failure and cardiorenal diseases: comparison at bench and bedside. In: Bauersachs J, Butler J, Sandner P, editors. Heart failure. Switzerland: Springer International Publishing AG; 2017. p. 271\u2013305."},{"key":"1719_CR17","doi-asserted-by":"publisher","first-page":"257","DOI":"10.1161\/HYPERTENSIONAHA.114.04488","volume":"65","author":"J Bauersachs","year":"2015","unstructured":"Bauersachs J, Jaisser F, Toto R. Mineralocorticoid receptor activation and mineralocorticoid receptor antagonist treatment in cardiac and renal diseases. Hypertension. 2015;65:257\u201363.","journal-title":"Hypertension"},{"key":"1719_CR18","doi-asserted-by":"publisher","first-page":"e147","DOI":"10.1016\/j.jacc.2013.05.019","volume":"62","author":"CW Yancy","year":"2013","unstructured":"Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE, Drazner MH, et al. 2013 ACCF\/AHA guideline for the Management of Heart Failure: a report of the American College of Cardiology Foundation\/American Heart Association task force on practice guidelines. J Am Coll Cardiol. 2013;62:e147\u2013239.","journal-title":"J Am Coll Cardiol"},{"key":"1719_CR19","doi-asserted-by":"publisher","first-page":"e137","DOI":"10.1161\/CIR.0000000000000509","volume":"136","author":"CW Yancy","year":"2017","unstructured":"Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE, Colvin MM, et al. 2017 ACC\/AHA\/HFSA focused update of the 2013 ACCF\/AHA guideline for the Management of Heart Failure: a report of the American College of Cardiology\/American Heart Association task force on clinical practice guidelines and the Heart Failure Society of America. Circulation. 2017;136:e137\u201361.","journal-title":"Circulation"},{"key":"1719_CR20","doi-asserted-by":"publisher","first-page":"14","DOI":"10.1111\/jch.12237","volume":"16","author":"MA Weber","year":"2013","unstructured":"Weber MA, Schiffrin EL, White WB, Mann S, Lindholm LH, Kenerson JG, et al. Clinical practice guidelines for the management of hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension. J Clin Hypertens (Greenwich). 2013;16:14\u201326.","journal-title":"J Clin Hypertens (Greenwich)"},{"key":"1719_CR21","doi-asserted-by":"crossref","unstructured":"Bolignano D, Palmer SC, Navaneethan SD, Strippoli GFM. Aldosterone antagonists for preventing the progression of chronic kidney disease, CD007004. Cochrane Database Syst Rev. 2014.","DOI":"10.1002\/14651858.CD007004.pub3"},{"key":"1719_CR22","doi-asserted-by":"publisher","first-page":"199","DOI":"10.1053\/j.ajkd.2007.10.040","volume":"51","author":"AS Bomback","year":"2008","unstructured":"Bomback AS, Kshirsagar AV, Amamoo MA, Klemmer PJ. Change in proteinuria after adding aldosterone blockers to ACE inhibitors or angiotensin receptor blockers in CKD: a systematic review. Am J Kidney Dis. 2008;51:199\u2013211.","journal-title":"Am J Kidney Dis"},{"key":"1719_CR23","doi-asserted-by":"publisher","first-page":"609","DOI":"10.1111\/jdi.12629","volume":"8","author":"LJ Sun","year":"2017","unstructured":"Sun LJ, Sun YN, Shan JP, Jiang GR. Effects of mineralocorticoid receptor antagonists on the progression of diabetic nephropathy. J Diabetes Investig. 2017;8:609\u201318.","journal-title":"J Diabetes Investig"},{"key":"1719_CR24","unstructured":"Blankenburg M, Fett A-K, Eisenring S, Haas G, Korn J, Gay A. Real life insights into the use of mineralocorticoid receptor antagonists in patients with diabetic and non-diabetic chronic kidney disease with and without heart failure. JASN. 2017; 28 (Suppl 1):528 (FR-PO484)."},{"key":"1719_CR25","doi-asserted-by":"publisher","first-page":"E459","DOI":"10.3390\/jcm7110459","volume":"7","author":"C-T Yang","year":"2018","unstructured":"Yang C-T, Kor C-T, Hsieh Y-P. Long-term effects of spironolactone on kidney function and hyperkalemia-associated hospitalization in patients with chronic kidney disease. J Clin Med. 2018;7:E459.","journal-title":"J Clin Med"},{"key":"1719_CR26","doi-asserted-by":"publisher","first-page":"554","DOI":"10.1111\/j.1365-2125.2004.02187.x","volume":"58","author":"MD Witham","year":"2004","unstructured":"Witham MD, Gillespie ND, Struthers AD. Tolerability of spironolactone in patients with chronic heart failure \u2013 a cautionary message. Br J Clin Pharmacol. 2004;58:554\u20137.","journal-title":"Br J Clin Pharmacol"},{"key":"1719_CR27","first-page":"215","volume":"5","author":"S Gandhi","year":"1999","unstructured":"Gandhi S, Salmon JW, Kong SX, Zhao SZ. Administrative databases and outcomes assessment: an overview of issues and potential utility. J Manag Care Spec Pharm. 1999;5:215\u201322.","journal-title":"J Manag Care Spec Pharm"}],"container-title":["BMC Nephrology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12882-020-01719-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s12882-020-01719-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12882-020-01719-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,2,25]],"date-time":"2021-02-25T00:14:14Z","timestamp":1614212054000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcnephrol.biomedcentral.com\/articles\/10.1186\/s12882-020-01719-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,2,26]]},"references-count":27,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["1719"],"URL":"https:\/\/doi.org\/10.1186\/s12882-020-01719-7","relation":{},"ISSN":["1471-2369"],"issn-type":[{"value":"1471-2369","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,2,26]]},"assertion":[{"value":"26 June 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 February 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 February 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The secondary data source used for the analysis meet all of the US Health Insurance Portability and Accountability Act compliance standards, ensuring patient anonymity. As such, approval from an institutional review board was not necessary.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"MB and AG are employees of Bayer AG. RGG is an employee of IQVIA. The following authors have received compensation for serving as consultants or speakers for, or they or the institutions they work for have received research support or royalties from, the companies or organizations indicated: AKF (IQVIA), CPK (Bayer AG), RGG (Bayer AG).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"61"}}